# K032377: Roche Diagnostics Hitachi Bicarbonate Liquid

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 21, 2003 after 20 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K842280 (1984). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031879: Cobas Integra Carbon Dioxide Assay, Roche Diagnostics Corp. (2003)

## Most influential descendants
- K071340: Carbon Dioxide (CO2), Scal, Nortrol and Abtrol (2007), 0 descendants of its own
- K060295: Carbon Dioxide (2006), 0 descendants of its own

## Indications for use
In vitro test for the quantitative determination of bicarbonate (HCO3') in human serum and plasma on Roche automated clinical chemistry analyzers. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K032377
Methodology: https://510kreport.com/methodology